1. Field of the Invention
This invention concerns a novel and improved drug-free treatment and prevention of alopecia and stress related diseases by using alternatively an ambient and a negative pressure. In particular, this invention concerns a treatment and prevention of alopecia by stimulating a hair growth by applying alternatively the ambient and negative pressure to the bald or balding scalp for several minutes once or several times a day. Headaches and other stress related diseases are treated and prevented in the same way by increasing the blood circulation to the affected areas. The stimulation is administered through a helmet connected to a vacuum means and equipped with a seal.
2. Background and Related Disclosures
Alopecia or baldness is a partial or complete loss of hair. Alopecia may result from genetic or nongenetic factors, from aging or from local or systemic disease and is very likely connected to stress and ravages of the force of gravity. Since the hair represents a symbol of youthfulness and virility, a social stigma and personal discomfort is often associated with balding.
Male pattern baldness is extremely common and it is believed that it is caused by and requires the presence of androgens. The male pattern type of alopecia may be fairly extensive. Female pattern alopecia is not infrequent but is usually confined to thinning of the hair and seldom ends with complete baldness.
Although many preparations, chemicals, diets, drugs or surgical treatments have been developed and proposed throughout the history, still there is no effective treatment available which would restore or stimulate the growth of the hair in balding person without patient's need to undergo lengthy and painful surgical hair transplant or using drugs which have severe side effects.
Many nonmedicinal hair restorers were tried containing vitamins, minerals, proteins, metals, enzymes and various medicinal treatments, as described below. These hair restorers are administered either systemically, orally or directly topically to a scalp or to the hair, and various concoctions were prepared containing one or more above listed ingredients alone or in combination with other "miraculous" substances.
In both cases of systemic or topical administrations, these treatments have invariably failed. That is so, first, because it is extremely unlikely that any treatment administered orally or otherwise systemically in fact reaches the hair follicles. Second, the topically administered treatment must cross a formidable barrier which the human skin provides against the penetration of any matter trying to enter the body through the skin. Thus, in order for any topically administered substance to penetrate the skin, to reach the depth of the hair follicle and to restore its function, such substance must be administered in a very high concentration and be formulated in a way which allows a passage through the skin barrier.
Medicinal treatments of alopecia include steroidal treatments, hormonal treatments and treatment with other drugs, such as recently discovered treatment with minoxidil, previously known cardiovascular drug.
A systemic corticosteroid treatment, which is often used to treat alopecia areata, a sudden hair loss in circumscribed areas, is accompanied by a variety of severe and undesirable secondary symptoms. The treatment with steroids cannot be justified merely for cosmetic reasons as it is invasive to the body's equilibrium. (The Merck Manual, 2281, 15th Edition (1987)). A systemic hormone treatment with female hormone estrogen has been shown to reverse male pattern alopecia in a limited way. However, the hair restorative effect of this treatment is uncertain particularly as it produces unacceptable side effects such as enlarged breasts in males, a lack of facial and body hair, and an elevated tone of voice. Another type of hormonal treatment of alopecia is an injection of female hormones, in dilute concentrations, directly into the scalp or, in alternative, rubbing the solution containing these hormones into a man's scalp. Similarly to other topically administered drugs and to the systemic steroidal treatments, such applications may improve hair growth but eventually they result in similar secondary side effects as described above.
Currently, the only known and effective drug treatment of alopecia is with a topically administered 3% solution of minoxidil, a potent anti-hypertensive drug. This treatment is not without problems. Following the treatment, high quantities of minoxidil in blood have been observed, causing some patients to experience the major side effects such as tachycardia, swelling and difficulty in breathing. Moreover, currently available topical minoxidil preparations are formulated in a mixture of alcohol and propylene glycol which formulation leaves unattractive film on the scalp. (PDR, 2184, 43rd Edition, (1989)).
Thus, it would be desirable to have available a drug-free treatment for alopecia which would eliminate all the above stated disadvantages or, in alternative, to have available a treatment which would allow a reduced dosage of the drug while achieving the desired result, i.e., the hair growth. Scalp massages are frequently recommended to the balding people under the premise that the massage helps to increase the flow of nutrients and oxygen to the hair follicles. Various gears have been developed to administer such massage to the scalp. Mostly, such devices are complicated, multi-component apparatuses which are expensive, hard to assemble, operate and disinfect. For example, U.S. Pat. No. 4,469,092 describes an electromechanical system for stimulating the human scalp. The system includes a rigid helmet with internal pad comprising stimulation members which directly contact the scalp of the patient. A vibration motor housed within the helmet mechanically vibrates the fingers of the pad. A vacuum means supposedly distributes vacuum in the helmet's interior during vibration to stimulate the scalp, however, no effective means for achieving the vacuum are disclosed. U.S. Pat. No. 4,765,316 improves the above system to make it portable so that both vibrator and the vacuum units are located within the helmet. A head vibrator unit is disclosed in the U.S. Pat. No. 3,763,853. U.S. Pat. Nos. 1,681,111, 4,566,137 and 4,287,613 generally describe cushioned helmets and hats. All the above described scalp stimulators and vibrators are heavy, complicated and costly equipments which generally require specially built-in electrical and mechanical means, such as special pads, vibrators and vacuum pumps.
The current invention provides easy, simple, cheap and uncomplicated method for treatment of alopecia by scalp suction stimulation performed by alternating an ambient and negative pressure. Moreover, the current invention is also useful for relieving stress-induced diseases such as headaches, particularly migraine and sinus headaches and other stress related conditions.